Browse Drug Recalls

942 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 942 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 942 FDA drug recalls in TX.

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DateProductReasonClassFirm
Jan 16, 2026 UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... Class I McKesson
Jan 6, 2026 AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each cGMP deviations. Class II Encon Safety Products Co
Dec 17, 2025 BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... Lack of Assurance of Sterlity Class II CareFusion 213, LLC
Dec 15, 2025 MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafi... Class I StuffbyNainax
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 29, 2025 POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... Class I Otsuka ICU Medical LLC
Oct 27, 2025 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... Lack of Assurance of Sterility: Potential for flexible container leaks. Class II Otsuka ICU Medical LLC
Oct 14, 2025 Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 14, 2025 Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBC... CGMP Deviations: Potential presence of metal particulate matter Class II FARMAKEIO OUTSOURCING LLC
Oct 10, 2025 R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... Presence of Particulate Matter Class II QuVa Pharma, Inc.
May 15, 2025 BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of... Class II CareFusion 213, LLC
May 2, 2025 Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Mult... Lack of Assurance of Sterility Class II Empower Clinic Services, LLC dba Empower Pharmacy
Mar 31, 2025 Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38... CGMP Deviations Class II Medisca Inc.
Mar 11, 2025 Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/A... Chemical contamination: presence of benzene Class II Fruit Of The Earth, Inc.
Mar 11, 2025 CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (... Chemical contamination: presence of benzene Class II Fruit Of The Earth, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I CareFusion 213, LLC
Jan 17, 2025 Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... cGMP Deviations: Product intended for quarantine was inadvertently distributed. Class II McKesson
Dec 18, 2024 Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... Non-Sterility Class I Alcon Research LLC
Nov 14, 2024 UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 cGMP Deviations: the firm initiated a recall after notification from the distributor that product... Class II MXBBB
Sep 5, 2024 Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... Lack of Assurance of Sterility Class II Empower Pharmacy
Aug 2, 2024 Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... Lack of Assurance of Sterility Class II EMPOWER CLINIC SERVICES LLC
Jun 26, 2024 Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... CGMP Deviations and Presence of Particulate Matter: Glass Class II Medisca Inc.
May 1, 2024 CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl... Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria Class II Pharma Nobis LLC
May 1, 2024 Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G... Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria Class II Pharma Nobis LLC
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
Apr 17, 2024 Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor ... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.